MY209364A - Stable vaccine compositions comprising inter alia live attenuated recombinant flavivirus and process for preparation thereof - Google Patents

Stable vaccine compositions comprising inter alia live attenuated recombinant flavivirus and process for preparation thereof

Info

Publication number
MY209364A
MY209364A MYPI2020001833A MYPI2020001833A MY209364A MY 209364 A MY209364 A MY 209364A MY PI2020001833 A MYPI2020001833 A MY PI2020001833A MY PI2020001833 A MYPI2020001833 A MY PI2020001833A MY 209364 A MY209364 A MY 209364A
Authority
MY
Malaysia
Prior art keywords
live attenuated
attenuated recombinant
inter alia
preparation
vaccine compositions
Prior art date
Application number
MYPI2020001833A
Inventor
Rajeev Mhalasakant Dhere
Leena Ravindra Yeolekar
Vinit Kumar
Rohit Bapurav Sonar
Sandeep Dinkar Baraskar
Rajeev Mehla
Shashikant Janardan Ghodekar
Original Assignee
Serum Institute Of India Pvt Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Serum Institute Of India Pvt Ltd filed Critical Serum Institute Of India Pvt Ltd
Publication of MY209364A publication Critical patent/MY209364A/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • C07K14/08—RNA viruses
    • C07K14/18—Togaviridae; Flaviviridae
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • C12N7/04—Inactivation or attenuation; Producing viral sub-units
    • C12N7/06—Inactivation or attenuation by chemical treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5254—Virus avirulent or attenuated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55561—CpG containing adjuvants; Oligonucleotide containing adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55566—Emulsions, e.g. Freund's adjuvant, MF59
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55572—Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55577—Saponins; Quil A; QS21; ISCOMS
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55583—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/70—Multivalent vaccine
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/24011—Flaviviridae
    • C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
    • C12N2770/24134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Stable lyophilized immunogenic compositions comprising inter alia live attenuated recombinant flaviviruses, more preferably live attenuated recombinant dengue viruses, atleast one carbohydrate, atleast one amino acid and is particularly amenable to rapid freeze-drying treatments wherein, the composition preserves desired characteristics of a virus, including virus viability, immunogenicity and stability. The said immunogenic composition is devoid of preservatives, polymers and surfactants. The methods for manufacturing said stable lyophilized immunogenic compositions.
MYPI2020001833A 2017-10-16 2018-10-10 Stable vaccine compositions comprising inter alia live attenuated recombinant flavivirus and process for preparation thereof MY209364A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201721036696 2017-10-16
PCT/IN2018/050645 WO2019077622A1 (en) 2017-10-16 2018-10-10 Stable vaccine compositions comprising inter alia live attenuated recombinant flavivirus and process for preparation thereof

Publications (1)

Publication Number Publication Date
MY209364A true MY209364A (en) 2025-07-03

Family

ID=66173564

Family Applications (1)

Application Number Title Priority Date Filing Date
MYPI2020001833A MY209364A (en) 2017-10-16 2018-10-10 Stable vaccine compositions comprising inter alia live attenuated recombinant flavivirus and process for preparation thereof

Country Status (24)

Country Link
US (1) US11660333B2 (en)
EP (1) EP3697897A4 (en)
JP (1) JP7261239B2 (en)
KR (1) KR102755215B1 (en)
CN (1) CN111655844B (en)
AR (1) AR114138A1 (en)
AU (1) AU2018352447B2 (en)
CA (1) CA3079151A1 (en)
CO (1) CO2020006037A2 (en)
CR (1) CR20200212A (en)
CU (1) CU24701B1 (en)
EA (1) EA202090967A1 (en)
GE (2) GEP20237575B (en)
MX (1) MX2020004085A (en)
MY (1) MY209364A (en)
PE (1) PE20210106A1 (en)
PH (1) PH12020550266A1 (en)
PY (1) PY1889910A (en)
SA (1) SA520411768B1 (en)
SG (1) SG11202003408TA (en)
TW (1) TWI812650B (en)
UA (1) UA127829C2 (en)
WO (1) WO2019077622A1 (en)
ZA (1) ZA202002852B (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2968516B1 (en) 2013-03-15 2022-01-12 Takeda Vaccines, Inc. Compositions and methods for dengue virus chimeric constructs in vaccines
WO2019112921A1 (en) 2017-12-07 2019-06-13 Merck Sharp & Dohme Corp. Formulations of dengue virus vaccine compositions
US11426461B2 (en) 2018-09-05 2022-08-30 Takeda Vaccines, Inc. Methods for preventing dengue and hepatitis A
CN114828885A (en) * 2019-12-10 2022-07-29 瑞普利金公司 Method for producing viral vectors
BR112022015272A2 (en) * 2020-02-04 2022-09-20 Regeneron Pharma TARGET RESIDUAL MOISTURE CONTENT FOR LYOPHILIZED DRUG PRODUCT
GB2600468A (en) * 2020-10-30 2022-05-04 Excivion Ltd Adjuvant composition
US12318439B2 (en) * 2021-05-09 2025-06-03 Board Of Regents, The University Of Texas System Attenuating viral mutations in protein genes
WO2023037387A2 (en) * 2021-09-08 2023-03-16 Serum Institute Of India Private Limited Freeze-dried viral combination vaccine compositions and process for preparation thereof
US20250177511A1 (en) * 2022-02-15 2025-06-05 Takeda Vaccines, Inc. Dengue vaccine batch mixing process
EP4356925B1 (en) * 2022-10-18 2025-09-10 Takeda Vaccines, Inc. Dengue vaccine formulation
EP4626574A1 (en) * 2022-11-29 2025-10-08 Takeda Vaccines, Inc. Large-scale flaviviral vaccine production and manufacture
WO2025027616A1 (en) * 2023-08-01 2025-02-06 Serum Institute Of India Private Limited Freeze-dried viral vaccine compositions and method of manufacturing thereof

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2681567C (en) * 2007-03-22 2016-07-19 The Regents Of The University Of Colorado, A Body Corporate Method of preparing an immunologically-active adjuvant-bound dried vaccine composition
EP2143440A1 (en) * 2008-07-09 2010-01-13 Sanofi Pasteur Stabilising agent and vaccine composition comprising one or several attenuated living flavivirus
US8785173B2 (en) * 2008-09-24 2014-07-22 Medimmune, Llc Methods for purification of viruses
WO2010146598A2 (en) * 2008-11-07 2010-12-23 Serum Institute Of India Ltd. Stable, dried rotavirus vaccine, compositions and process for preparation thereof
MX349294B (en) * 2010-12-02 2017-07-21 Oncolytics Biotech Inc Lyophilized viral formulations.
WO2013106337A1 (en) 2012-01-09 2013-07-18 Sanofi Pasteur Biologics, Llc Purification of flaviviruses
US10004795B2 (en) 2015-09-08 2018-06-26 Fundacao Butantan Process for preparing an attenuated tetravalent dengue vaccine
WO2017056101A1 (en) * 2015-09-30 2017-04-06 Panacea Biotec Limited Stable live attenuated recombinant dengue vaccine
WO2017147318A1 (en) * 2016-02-23 2017-08-31 The Regents Of The University Of Colorado, A Body Corporate Compositions and methods for making and using thermostable immunogenic formulations with increased compatibility of use as vaccines against one or more pathogens

Also Published As

Publication number Publication date
CU20200036A7 (en) 2021-03-11
TW201922272A (en) 2019-06-16
AU2018352447A1 (en) 2020-06-11
SA520411768B1 (en) 2023-12-21
UA127829C2 (en) 2024-01-17
ZA202002852B (en) 2021-03-31
AR114138A1 (en) 2020-07-29
EA202090967A1 (en) 2020-08-12
CR20200212A (en) 2020-07-17
KR20200088326A (en) 2020-07-22
WO2019077622A1 (en) 2019-04-25
MX2020004085A (en) 2020-12-03
JP7261239B2 (en) 2023-04-19
GEP20237575B (en) 2023-12-25
CA3079151A1 (en) 2019-04-25
SG11202003408TA (en) 2020-05-28
PY1889910A (en) 2020-04-17
KR102755215B1 (en) 2025-01-20
EP3697897A1 (en) 2020-08-26
JP2020537691A (en) 2020-12-24
US20210187092A1 (en) 2021-06-24
BR112020007513A2 (en) 2020-10-06
GEAP202315338A (en) 2023-07-10
CO2020006037A2 (en) 2020-08-10
CN111655844B (en) 2024-05-24
PH12020550266A1 (en) 2021-03-01
CN111655844A (en) 2020-09-11
AU2018352447B2 (en) 2025-04-03
PE20210106A1 (en) 2021-01-19
US11660333B2 (en) 2023-05-30
EP3697897A4 (en) 2022-02-23
CU24701B1 (en) 2024-04-08
TWI812650B (en) 2023-08-21

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